Abilify Maintena

What is Abilify Maintena?

Abilify Maintena is a prescription medicine given by injection by a healthcare professional for:

• treatment of schizophrenia in adults
• maintenance treatment of bipolar I disorder in adults

It is not known if Abilify Maintena is safe and effective in children under 18 years of age.

What is the most important information I should know about Abilify Maintena?

Each injection of Abilify Maintena must be administered by a healthcare professional only.
Abilify Maintena may cause serious side effects, including:

• Increased risk of death in elderly people with dementia-related psychosis. Abilify Maintena is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

Who should not take Abilify Maintena?

Do not receive Abilify Maintena if you are allergic to aripiprazole or any of the ingredients in Abilify Maintena. See the end of this Medication Guide for a complete list of ingredients in Abilify Maintena.

What should I tell my healthcare provider before taking Abilify Maintena?

Before receiving Abilify Maintena, tell your healthcare provider about all your medical conditions, including if you:

• have never taken aripiprazole before
• have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving Abilify Maintena and during your treatment.
• have or had seizures (convulsions)
• have or had low or high blood pressure
• have or had heart problems or a stroke
• have or had a low white blood cell count
• have problems that may affect you receiving an injection in your arm or buttocks
• are pregnant or plan to become pregnant. It is not known if Abilify Maintena will harm your unborn baby.
  • If you become pregnant while receiving Abilify Maintena, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
• are breastfeeding or plan to breastfeed. Abilify Maintena can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive Abilify Maintena.

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.
Abilify Maintena and other medicines may affect each other causing possible serious side effects. Abilify Maintena may affect the way other medicines work, and other medicines may affect how Abilify Maintena works.
Your healthcare provider can tell you if it is safe to receive Abilify Maintena with your other medicines. Do not start or stop any medicines during treatment with Abilify Maintena without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Abilify Maintena?

• Follow your Abilify Maintena treatment schedule exactly as your healthcare provider tells you to.
• Abilify Maintena is an injection given in your arm or buttock by your healthcare provider 1 time every month. You may feel a little pain in your arm or buttock during your injection.
• After your first injection of Abilify Maintena you should continue your current antipsychotic medicine for 2 weeks.
• You should not miss a dose of Abilify Maintena. If you miss a dose for some reason, call your healthcare provider right away to discuss what you should do next.

What should I avoid while taking Abilify Maintena?

• Do not drive, operate machinery, or do other dangerous activities until you know how Abilify Maintena affects you. Abilify Maintena may make you feel drowsy.
• Do not drink alcohol while you receive Abilify Maintena.
• Do not become too hot or dehydrated while you receive Abilify Maintena.
  • Do not exercise too much.
  • In hot weather, stay inside in a cool place if possible.
  • Stay out of the sun.
  • Do not wear too much clothing or heavy clothing.
  • Drink plenty of water.

What are the possible side effects of Abilify Maintena?

Abilify Maintena may cause serious side effects, including:

• See "What is the most important information I should know about Abilify Maintena?"
• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
• Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest emergency room right away if you have some or all of the following symptoms of NMS:
  • high fever
  • confusion
  • changes in pulse, heart rate, and blood pressure
  • stiff muscles
  • sweating
• Uncontrolled body movements (tardive dyskinesia). Abilify Maintena may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving Abilify Maintena. Tardive dyskinesia may also start after you stop receiving Abilify Maintena.
• Problems with your metabolism such as:
  • high blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who receive Abilify Maintena. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start receiving Abilify Maintena and during your treatment.
    Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving Abilify Maintena:
    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused, or your breath smells fruity
  • Increased fat levels (cholesterol and triglycerides) in your blood.
  • Weight gain. You and your healthcare provider should check your weight regularly.
• Unusual urges. Some people receiving Abilify Maintena have had unusual urges such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Low white blood cell count
• Seizures (convulsions)
• Problems controlling your body temperature so that you feel too warm. See " What should I avoid while receiving Abilify Maintena?"
• Difficulty swallowing

The most common side effects of Abilify Maintena include: weight gain, inner sense of restlessness such as feeling like you need to move (akathisia), injection site pain, or sleepiness (sedation).
These are not all the possible side effects of Abilify Maintena. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Abilify Maintena

If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Abilify Maintena that is written for healthcare professionals.

How should I store Abilify Maintena?

Pre-filled dual chamber syringe: Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use.

Vial: Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F)

What are the ingredients in Abilify Maintena?

Active ingredient: aripiprazole monohydrate
Inactive ingredients: carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide

For more information, go to www.ABILIFYMAINTENA.com or call 1-800-441-6763.